Simple, Fast, and Beautiful

Vessix has created a second generation percutaneous renal denervation system for the treatment of hypertensive patients.

Vessix Vascular, a pre-revenue stage medical technology company, and product innovation consultancy Karten Design introduce the V2 Renal Denervation System – a new device treatment for high blood pressure.

In as little as 30 seconds per artery, the Vessix V2 System performs a one-time minimally invasive catheter-based percutaneous procedure shown to reduce, significantly, blood pressure.

This new technology has the potential to help the one in three adults in the United States who suffer from hypertension – a condition more common than cancer, diabetes, and coronary artery disease combined. Today, anti-hypertensive drugs are the primary treatment for hypertension. However, despite the widespread use of drugs, only about half of hypertensive patients around the world have good control over their hypertension, even when taking multiple medications at optimal dosages. A change is now underway.

The V2 System performs a new procedural treatment called renal denervation, which Dr. Mehmet Oz has called it, “a profound game changer.” It uses a short blast of radiofrequency (RF) energy to disable the nerves surrounding the arteries leading to the kidneys, treating one of the key physiological contributors to hypertension.

Vessix’s patented V2 Catheter, a balloon catheter with a unique configuration of RF electrodes mounted on its exterior, makes this procedure faster and safer. It delivers precise temperature-controlled RF energy from the V2 RF Generator to both renal arteries in 60 seconds, while the only other competitively marketed Renal Denervation system takes 50 to 60 minutes. The rapidity of the V2’s treatment promises to reduce patient discomfort as well as exposure to radiation for both the patient and the interventional cardiologist performing the procedure.

Vessix Vascular chose Karten Design, an award-winning product innovation consultancy with a 28-year history of commercializing new medical devices, to give physical form to its technology. Tasked with creating a strong visual identity, for a new company’s products as it sought funding to test and commercialize its system, was Karten Design.

“I wanted a design that immediately communicates that there is something new and exciting going on – even before I explain how the product works,” states Vessix CEO Raymond Cohen. “The goal was to have the product look faster, sexier, and more advanced than any other piece of equipment found in the hospital.”

Karten Design expressed all of the Vessix technology’s advantages – its speed, its simplicity, as well as its benefits for the patient – in a beautiful design for the V2 RF Generator that advances this future-forward technology toward commercialization.

“Our design effort was all about simplifying complexity,” says Karten Design Principal Stuart Karten. “By expressing Vessix’s technology in an elegant, easy-to-use product, we are making it relatable and giving it an identity that people can connect with. This is just as important with medical devices as it is with consumer technology, if not more so because the stakes are so high.”

Design Innovation
To ensure the system’s design supports the physician’s natural workflow in the catherization lab, Karten Design worked with Vessix during the early phases of product definition, visiting hospital cath labs and interviewing doctors to determine the system’s ideal usage. Karten Design researchers and designers learned about the human factors surrounding a catheter-based procedure, including visibility, access, and sterility. Resulting design innovations include the following areas.

Flexible Configuration
Designers considered a configuration that would support the broadest range of cath labs in the United States and the rest of the world. To allow doctors the flexibility to move the V2 Generator from room to room, Karten Design had the generator head mount on a wheeled cart. Locking wheels keep the machine in place once treatment has begun.

Design and Form
Because the generator would never have to sit on a table, it did not need a flat bottom. Design of the sweeping, parabolic enclosure, without back or bottom, is to be beautiful at every angle; all 360° of the product reflect the same high-quality finish and attention to detail. Cantilevered beyond the cart pole, the RF Generator appears to be hovering – an effect that adds to the device’s intrigue.

Material Use
A new palette of materials suggests consumer electronics more than being hospital equipment. Made from CNC-machined aluminum, design of the generator is to take advantage of the manufacturing process to achieve stunning details, such as the interlocking diamond texture of the device’s side housings.

The V2 System consists of the V2 Catheter, a low-pressure balloon catheter with RF electrodes mounted on the exterior of the balloon, the V2 Bipolar RF generator, and connecting cables.

Graphic User Interface
To gain traction with busy physicians, the system needed to be easy to learn and use. Karten Design built a custom graphic user interface from the ground-up to reinforce the simplicity of the 30-second procedure. The user interface is minimal, consisting of one control button. The brilliant, full-color, iPad-inspired display screen visualizes what is happening during the procedure. It displays only critical, actionable information. Before initiation of treatment, it confirms the optimal position of the catheter electrodes, and prompts the user to deliver therapy. After performing the therapy, the display summarizes relevant information for reporting.

Vessix made its first public presentation of the new V2 Renal Denervation System at LINC 2012 in Leipzig, Germany on January 26, 2012. Vessix has already begun a 64-patient human clinical in February in Europe. The V2 Renal Denervation System has received Conformite Europeenne (CE) Mark approval for the treatment of hypertension.

Vessix Vascular Inc.
Laguna Hills, CA
vessixvascular.com

Karten Design
Marina Del Ray, CA
kartendesign.com